ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery

Sep 16, 2023

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Plum 360, Plum A+ and Plum A+3 are large volume infusion pumps used to give fluids to patients in precisely controlled infusion amounts and rates. The system delivers blood or blood products, drugs, and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration.

The batteries and replacement batteries are used when the pump is not plugged into AC power, for example when a patient is being transported.

ICU Medical is recalling replacement batteries for the Plum 360, Plum A+, and Plum A+3 Infusion Systems because a manufacturing defect has substantially diminished how long they can be used to run the system. If the pump is running on battery power and there is no AC power backup available, the system may shut down an ongoing infusion and power down sooner than expected.

This issue may cause serious injury or death to patients due to interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.

ICU Medical has received 54 (Plum 360) and 465 (Plum A+/A+3) complaints regarding this issue and has not reported any injuries or deaths. However, the FDA has identified an adverse event that may be related to the recall issue.

On March 22, 2023, ICU Medical sent an Urgent Medical Device Correction letter to customers with the following recommendations:

If potentially affected products were distributed to customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected].

ICU Medical will replace all batteries affected by this issue and will contact customers when batteries are available to schedule a battery replacement.

FDA believes the actions above adequately mitigate the risks until a more permanent correction can be made.

To report adverse events or product complaints:Global Complaint Management1-844-654-7780 (M-F, 8:00am – 5:00pm CT) or [email protected]

Additional information or assistance:Technical Assistance1-800-241-4002, option 3 (M-F, 8:00 am – 6:00 pm CT)

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

05/22/2023